Roundtable

The Tennessean will host an Information Roundtable on the meningitis outbreak from 5 to 7 p.m. Monday at the First Amendment Center in Nashville. RSVP at http://meningitis.eventbrite.com/ or by joining our Facebook group at www.facebookcom/groups/meningitisoutbreak. Journalists covering the story will be on hand to answer questions directly from those affected, their families and others interested in this story. We have invited health care professionals, government leaders and others in the hopes those concerned about the outbreak will be able to ask questions directly of those involved in the story.

Meningitis HotlineCall 1-800-222-1222 and immediately press option 1 to be connected with a person from the poison-control hotline who can answer questions about meningitis. Anyone treated at Saint Thomas Outpatient Neurosurgery Center can call the clinic at 615-341-3425 with inquiries. More information is at www.stthomas.org/ meningitis.

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State and federal regulators joined together Thursday in calling for congressional action to prevent a repeat of the ongoing fungal meningitis epidemic that has taken 14 lives and sickened 169, taking its heaviest toll in Tennessee.

“We urge Congress to act quickly so there is clear authority,” said Madeleine Biondolillo, director of the office of health safety for the Massachusetts Health Department.

Cases rose to 49 in Tennessee, but no new deaths were reported, the Tennessee Department of Health said. Six Tennesseans have died.

“We want to work with Congress and the compounders,” said Deborah M. Autor, a deputy commissioner with the U.S. Food and Drug Administration, citing conflicting court rulings on the authority of the federal government to regulate drug compounders like New England Compounding Center, the suspected source of tainted spinal steroid doses.

“We need to come together and work together,” she said. “It’s really unfortunate that it takes a crisis to bring this kind of change. But that often is the case. It is in crisis that we have the opportunity to make change.”

In response to questions about why state and federal officials did not act sooner even though serious violations at the facility were detailed in a 2006 warning letter, both Biondolillo and Autor blamed vagueness in their legal authority.

“I will say that enforcement in this case and in other compounding cases is complicated greatly by litigation and by a lack of clarity in the law,” Autor said.

Biondolillo said Massachusetts laws and regulations don’t place a cap on the volume compounders can produce.

“The interstate aspect is something that bears looking at on a federal level,” Biondolillo said.

However, while stressing that the investigation is ongoing, she said the Framingham company appears to have violated state regulations requiring an individual prescription for every dose produced by compounders.

“It looks like they have violated that regulation despite their assertions,” she said.

14,000 injected

Dr. J. Todd Weber of the U.S. Centers for Disease Control and Prevention, who heads the team looking into the outbreak, said the number of people who are believed to have received injections from three tainted lots of the drug has grown from about 13,000 to 14,000. About 12,000 of those people have now been contacted.

“Given the severity of fungal meningitis, time is of the essence,” Weber said. “We know we can save lives by identifying patients early and getting them on appropriate antifungal therapy.”

With new information coming out daily on the unfolding health crisis, Weber was reluctant to state an “attack rate” — the rate of infection among people who received the injections.

“We know we are not out of the woods yet,” said Weber, adding that patients and doctors need to remain vigilant for several months more.

The patients at risk got steroid injections at 75 outpatient clinics in 23 states, either in the spinal area or in the knee, shoulder or ankle. The disease cannot be spread from person to person.

2 fungi at work

One fungus found in the patients — exserohilum — has never before been seen as a cause of fungal meningitis, Weber said.

“This is new territory,” he said.

Patients who got the injections and come down with meningitis should be treated with
antifungals even if spinal taps do not detect the presence of fungi, Weber said.

“We know that a fungus such as exserohilum can be difficult to detect in samples from patients,” he said. “Patients and their clinicians should not assume that fungal testing is negative means there is no infection.”

Although aspergillus was the fungus identified in the first confirmed case, other infections indicate the primary culprit is exserohilum, which has been detected in 10 cases by the CDC. Other labs have confirmed an additional three cases of exserohilum, Weber said.

Joint injected

Weber said Michigan health officials have turned up the first suspected case of a patient getting an infection in a joint from one of the suspected lots. Tests are still ongoing, he said, but the unidentified patient got an injection of methylprednisolone acetate and now has an infection.

Weber also noted that the two medications now being used to treat those who have contracted fungal meningitis “can be very strong.”

He said a panel of experts has been convened to review the accumulating data and determine the best treatment for those who contract meningitis.

“We are working quickly to get as much information as possible,” Weber said.

TN hit hardest

So far, more than 50 sealed vials of the recalled steroid medicine linked to the outbreak have tested positive for the presence of a fungus, Autor said. Tests are ongoing to pinpoint the type.

Asked about the apparent disparity in the number of cases in the 23 states where the drugs were distributed, Weber said that some states got a small number of doses.

Tennessee, he said, got the most.

New England Compounding has since recalled all of its products. Although several states have acted to revoke pharmaceutical permits for the company, Tennessee records on Thursday showed no change in the firm’s licensure status.

The license is listed as active and valid until next year. The next scheduled meeting of the Tennessee Board of Pharmacy is Nov. 14-15.

Autor detailed how state and federal inspectors have expanded their investigation to include a second Massachusetts company, Ameridose LLC, which has common ownership with New England Compounding.

She noted that there is no evidence to date that any of the second firm’s products are tainted, but it has agreed to halt production for 12 days.